BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ STAPHSR

    MDR report key: 22903783 · Received August 27, 2025

    Report

    Report Number
    3007420875-2025-00135
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    July 27, 2025
    Report Date
    September 18, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904434199
    PMA / PMN Number
    K132822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ STAPH SR KIT (REF. (B)(4)) FROM LOT 5052451 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT A FALSE POSITIVE MRSA RESULT WITH THE BD MAX¿ STAPH SR KIT LOT 5052451. THE SAMPLE OBTAINED A MRSA NEGATIVE RESULT IN CULTURE AND WITH THE CEPHEID ASSAY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ STAPH SR ASSAY INDICATED THAT LOT 5052451 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. DESPITE MULTIPLE ATTEMPTS MADE TO RECEIVE INFORMATION, NO DATA WAS AVAILABLE FOR THE INVESTIGATION. WITHOUT DATA, BD IS UNABLE TO IDENTIFY THE CAUSE OF THE CUSTOMER ISSUE. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE BD MAX¿ STAPH SR KIT LOT 5052451. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION SINCE NO TREND WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN. D2: ADDITIONAL MEDICAL DEVICE TYPE: NQX. E1: INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A FALSE POSITIVE MRSA PATIENT RESULT WAS OBTAINED. CULTURE AND CEPHEID DID NOT DETECT MSRA. CEPHEID DETECTED STAPH AUREUS AND MEC. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ STAPHSR, A FALSE POSITIVE MRSA PATIENT RESULT WAS OBTAINED. CULTURE AND CEPHEID DID NOT DETECT MSRA. CEPHEID DETECTED STAPH AUREUS AND MEC. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251240 BD MAX¿ STAPHSR SEE H11 OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5052451 00382904434199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown